Rupture of Anterior Cruciate Ligament
Conditions
Keywords
Anterior cruciate ligament reconstruction
Brief summary
Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide analgesia for the front of the knee. Postoperatively, these patients will often report pain in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee results in blockade of the genicular nerves of the posterior knee. These nerves originate off of the tibial and common peroneal nerves and their blockade will result in improved posterior knee pain relief and may decrease narcotic consumption compared to patients who receive the same infiltration with normal saline.
Detailed description
Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery. At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.
Interventions
DRUGBupivacaine
30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. patients who are presenting for ACL reconstruction 2. candidates for peripheral nerve blocks patients 3. ASA 1-3
Exclusion criteria
1. Patient refusal 2. ASA Classification of 4 or higher 3. Pre-existing neuropathy in the femoral or sciatic distribution 4. Coagulopathy 5. Infection at the site 6. Non-English speaking or non-reading patients 7. Chronic opioid use (\>3months) 8. Pregnancy 9. Any other contra-indication to regional anesthesia 10. Failed femoral nerve block 11. Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 24 hours | Opioid consumption (mg morphine equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Pain Burden at 24hrs | Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10. |
| Patient Satisfaction | 24hr | Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied). |
| Quality of Recovery (QoR15) | 24hrs | Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = none of the time to 10 = all of the time; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Drug Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 | 8 |
| Preservative Free Normal Saline Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | Study Drug | Preservative Free Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 29 years | 27 years |
| Region of Enrollment United States | 8 participants | 10 participants | 18 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
Primary
Opioid Consumption
Opioid consumption (mg morphine equivalents)
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Drug | Opioid Consumption | 50 mg morphine equivalents |
| Preservative Free Normal Saline | Opioid Consumption | 70 mg morphine equivalents |
p-value: 0.18Wilcoxon (Mann-Whitney)
Secondary
Pain Score
Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
Time frame: Pain Burden at 24hrs
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Drug | Pain Score | Pain Score at Rest | 102 units on a scale |
| Study Drug | Pain Score | Pain Score during plantar flexion | 115 units on a scale |
| Preservative Free Normal Saline | Pain Score | Pain Score during plantar flexion | 128 units on a scale |
| Preservative Free Normal Saline | Pain Score | Pain Score at Rest | 135 units on a scale |
Comparison: At Restp-value: 0.86Wilcoxon (Mann-Whitney)
Comparison: Plantar Flexionp-value: 0.89Wilcoxon (Mann-Whitney)
Secondary
Patient Satisfaction
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
Time frame: 24hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Drug | Patient Satisfaction | 8 units on a scale |
| Preservative Free Normal Saline | Patient Satisfaction | 8 units on a scale |
p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary
Quality of Recovery (QoR15)
Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = none of the time to 10 = all of the time; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.
Time frame: 24hrs
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Drug | Quality of Recovery (QoR15) | 96 units on a scale |
| Preservative Free Normal Saline | Quality of Recovery (QoR15) | 102 units on a scale |
p-value: 0.82Wilcoxon (Mann-Whitney)